Position: R&D API
Company: Titan Laboratories Pvt. Ltd.
Location: Mahad
Experience Required: 2 to 4 years
Educational Qualification: M. Pharma, B. Pharma, or equivalent in Pharmaceutical Sciences, Chemistry, or related fields
Job Responsibilities
API Development and Optimization:
- Develop and optimize synthetic routes for active pharmaceutical ingredients (APIs) to achieve desired purity, yield, and cost-effectiveness.
- Scale up API synthesis from laboratory to pilot and commercial scale.
- Conduct experiments to improve API quality, stability, and efficacy.
Formulation and Process Development:
- Collaborate with formulation scientists to support the integration of APIs into final dosage forms.
- Develop novel API formulations and optimize processes for large-scale manufacturing.
- Conduct stability studies to ensure APIs meet regulatory standards.
Regulatory Compliance and Documentation:
- Ensure compliance with cGMP, ICH, and regulatory requirements in API development processes.
- Prepare and review documentation for regulatory submissions, including DMFs and batch records.
- Assist in preparing dossiers for international regulatory submissions.
Research and Innovation:
- Stay updated with the latest scientific advancements and industry trends in API development.
- Implement innovative technologies and methodologies to enhance API production.
- Conduct literature reviews and feasibility studies for new API developments.
Quality Control and Troubleshooting:
- Support analytical and quality control teams in API testing and analysis.
- Troubleshoot and resolve API production, quality, and performance issues.
- Investigate deviations, perform root cause analyses, and implement corrective actions.
Collaboration and Reporting:
- Collaborate with production, quality assurance, and regulatory affairs teams.
- Prepare detailed research reports and progress updates.
- Present findings and project updates to management and stakeholders.
Key Skills and Competencies
- Strong knowledge of synthetic organic chemistry and API production processes.
- Hands-on experience in API development, scaling up, and process optimization.
- Familiarity with regulatory requirements (FDA, EMA, etc.) for API development.
- Proficient in problem-solving, analysis, and troubleshooting.
- Excellent communication and teamwork skills.
How to Apply
Interested candidates are encouraged to send their CV to shweta.m@titanpharma.com.